Quality Control Specialist Ii

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Req# BP296
- **This role requires the ability to work flexible 8 hour shifts, which include working early mornings and late evenings depending on requirements.**

**The Company**

BioPharma Services Inc. is a subsidiary of Think Research.

BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma.

Through each success, and even some failures, the perpetual drive to make BioPharma great has been determined by the will and dedication of our people. The will to empower their colleagues, friends and teammates to excel in all facets of clinical research and inspire performance to achieve greatness.

It is with this same culture and brand of excellence that we welcome our clients. To experience the team community that has propelled us into a global leader in medical research, to be a client-focused partner, where people and patients matter.

Again, we invite you to come and meet our people. Our people who have learned that success is better achieved and celebrated as a team than as an individual.

**Why Us?**
- It's not every day that you have the chance to change the way your friends and family are cared for - Make an impact
- Everything we do - and we do it with passion - is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.
- We’re growing, and so will you with leaders who will support your development through mentorship and other opportunities
- Collaborative, creative, dynamic and flexible work environment, with a start-up spirit

**You Will Have The Opportunity To**:

- Assist in ensuring efficiency and mobilization of the QC staff to achieve expected results
- Assist in maintaining quality standards for QC and ensures adherence to study protocols, BPSI, SOPs, Directives, and ICH-GCPs guidelines and regulatory requirements
- Assists QC staff in addressing study-related issues while providing guidance to QC staff
- Ensure all study-related activities (especially BA/BE studies) are performed in compliance with Protocol, BPSI SOPs, and regulations
- Ensure all prepared study source documents and/or forms (especially BA/BE studies) are in accordance to protocols, SOPs, and regulations
- Ensure that all study-related documentation is reviewed to confirm the quality, reliability, accuracy, completeness and consistency in accordance with Protocols, SOPs, GCP guidelines, and applicable regulatory requirements, as well as, adhere to the established timelines
- Review all other study-related documentation: medical screening files, pharmacy labels, and files
- Ensure the conduct of clinical trial according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BPSI SOPs at all times
- Work closely with CRCs to ensure studies are conducted properly with high quality and high efficiency
- Observe, on a random basis, clinical procedures during the conduct of studies, sample bundling, and shipping process
- Provide reports of the reviewed data to relevant personnel/department
- Develop and utilize QC Checklist or other QC tools designed to document the QC review process
- Assist with training of new QC Staff
- Participate in the review of SOPs and Protocols
- Performs other tasks and projects as assigned

**What You Will Bring**:

- Completed Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
- 1-2+ years of relevant clinical research experience, knowledge of ICH-GCPs
- Professional experience working in CRO considered an asset
- Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
- Excellent attention to detail
- Excellent communication skills
- Excellent computer skills
- Certification in Clinical Research is an asset
- Think Research and all subsidiaries are proud to be an equal opportunity employer and is committed to creating a diverse and inclusive workplace, free of discrimination and harassment._
- We provide equal employment opportunities (EEO) to all employees and applicants regardless of race, colour, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status._
- We are committed to providing accommodations for people with disabilities. Should you require an accommodation, we would like to work with you to meet your needs._

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